A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (AVONELLE-X)

A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (AVONELLE-X)

This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab 6 milligrams (mg) administered by intravitreal injection at a personalized treatment interval to participants with neovascular age-related macular degeneration who enrolled in and completed one of the Phase III studies: GR40306 (NCT03823287) or GR40844 (NCT03823300), also referred to as the parent studies. Eligible patients who consent to participate in this study will be enrolled upon completion of the end-of-study visit in the parent study.


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 1280 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: The first 12 weeks of this study will be a masked period (to transition from the multi-arm parent studies) during which participants may receive either faricimab or sham injection. Participants and physicians will be masked only to the faricimab treatment interval. After the Week 12 treatment procedure, this study will follow an open-label design. The BCVA examiner will remain masked for the duration of this long-term extension study.
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (AVONELLE-X)
Estimated Study Start Date: April 13, 2021
Estimated Primary Completion Date: August 9, 2024
Estimated Study Completion Date: August 9, 2024

Arm:
- Experimental: Faricimab

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